Clinical Trial

EEG Biomarker Study for Participants in the Neurolief "MOOD" Trial

Active, Not Recruiting
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Summary
This study will collect EEG data at 3 time points from up to 40 adults who are enrolled in a double clinical trial investigating a device that delivers noninvasive, self-administered external Combined Occipital and Trigeminal Neurostimulation (eCOT-NS) treatment for Major Depressive Disorder (Relivion®DP). Baseline (Pre-treatment) Frontal EEG Alpha Oscillations (Power) will be compared post-stimulation power.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2021-12-16; most recent amendment 2024-12-03.
Status change: Enrolling by Invitation → Active, Not Recruiting 2024-06-13
Trial Details
NCT Number NCT05178784
Lead Sponsor Butler Hospital
Collaborators: Neurolief Ltd., University of North Carolina, Chapel Hill
Conditions Depression
Enrollment 40 participants
Start Date 2021-11-16
Primary Completion 2024-12-03 (estimated)
Study Completion 2025-11-16 (estimated)
Updated on ClinicalTrials.gov 2024-12-05